Half or more of HIV transmission events may occur within the period of high infectivity (and often high risk behavior) that can last 11 months or more after a person is initially infected. Unfortunately, neither test-and-treat intervention methods nor Acute HIV Infection projects have found effective ways to intervene against transmission during this risky "recent infection" period. The investigators seek to develop effective intervention techniques against HIV transmission during the recent infection period using a combination of injection-, sexual- and social-network-based contact tracing methods; community alerts in the networks and venues of recent infectees; and the logic of going "up" and "down" infection chains.

The investigators first Aim is to develop and evaluate ways to locate "seeds," defined as drug users and other people who have recently been infected. The investigators second Aim targets members of seeds' networks and people who attend their venues. The investigators will test them for acute and for recent infection, and alert them to the probability that their networks contain highly-infectious members so they should reduce their risk and transmission behaviors for the next several months to minimize their chances of getting infected. This may also reduce transmission by untested people with recent infection. Community, network and venue education about the need and value of supporting those with recent infection should reduce stigma. The investigators third Aim is to reduce HIV transmission and to develop new ways to evaluate "prevention for positives" generally as well as The investigators own success in reducing transmission.

The investigators will do this using a combination of follow-up interviews and testing, including of viral loads; phylogenetic techniques; and discrete event simulation modeling to assess The investigators effectiveness.

Further study details as provided by National Development and Research Institutes, Inc.:

Primary Outcome Measures:

Reduction in estimated HIV transmission [ Time Frame: The investigators will evaluate this 1, 2, 3 & 4 years after recruitment begins ] [ Designated as safety issue: No ]

Using phylogenetic techniques and network-based simulation modeling, teh investigators will analyze whether transmission of HIV got reduced in the city (or its key populations) as a whole. Phylogenetic analysis is not limited to study participants.

Secondary Outcome Measures:

Numbers of people with recent and acute HIV infection enrolled into the study and then intervened with [ Time Frame: The investigators will evaluate this 1 year, 2 years, 3 years and 4 years after recruitment starts ] [ Designated as safety issue: No ]

Comparison will be of numbers in the intervention group as compared with the numbers enrolled and intervened with in a comparison arm where index cases will be non-recent HIV positives. This is a measure of our success in enrolling recently and acutely infected people; and then additional records over the duration of the study of how well we did in getting them into and keeping them into treatment.

Other Outcome Measures:

Transmission behaviors among people with recent or acute HIV infection [ Time Frame: from intake to intended-6 month follow up ] [ Designated as safety issue: No ]

This is an exploratory and developmental study, so the investigators will be using a range of risk behaviors and metrics on risk behaviors as outcome variables. The behaviors include numbers of female and male partners of various categories, condom use with each category; use of drugs before or during sex; group sex behaviors; and a range of injection drug use behaviors and partnership characteristics for those who inject drugs.

Subjects: LAg+ recent HIV infection testees & referrals with recent/acute infection; those in social/risk networks of index subjects; people who go to their venues. We'll network trace direct contacts of Index Cases & network/venue members of contacts; and maybe 3rd ring as exploratory part of project. We'll test network/venue members for recent & acute HIV. If they have recent/acute HIV infection, their network/venue contacts will be traced. We'll refer HIV+ Primary arm participants for medical/social evaluation and treatment; those with recent/acute infection on expedited scheduling and case management. We will distribute "community alerts" to warn people in the social environments of recent/acute infectees to be super-careful in their behaviors for the next 6 months; to tell them how to be safer; and to repeat the importance of assisting rather than stigmatizing anyone they suspect has recently become infected.

Other: Assays

May vary across sites

Other Names:

Sedia Limited Avidity Assay

HIV antibody tests

HIV RNA testing

Other: HIV medical care

This will be expedited and assisted via community outreach for Recents and Acutes

Other Names:

Treatment for HIV to reduce viral load and to improve health

Treatment as prevention

Other: Social network and venue tracing

This is described in Arms 1 and 2

Other Name: This is described in Arms 1 and 2

Other: Community alerts

When we find recently or acutely infected participants, we will issue community alerts as described in Arm descriptions

Other: Community education

Throughout the study we will educate affected communities about recent and acute HIV infection and about the importance of avoiding stigma

Behavioral: HIV counseling

As part of HIV testing, we will provide participants with standard counseling

Active Comparator: Contact tracing of long-term HIV+ people

We will start with 50 subjects in each city who test HIV+ but LAg negative—and who report they have just learned they are HIV+. We will recruit their sexual and injection partners, and other risk environment contacts, for two steps, as in Primary Arm. HIV+ will be referred for treatment; recent/acutes on expedited and assisted basis.

Other: Assays

May vary across sites

Other Names:

Sedia Limited Avidity Assay

HIV antibody tests

HIV RNA testing

Other: HIV medical care

This will be expedited and assisted via community outreach for Recents and Acutes

Other Names:

Treatment for HIV to reduce viral load and to improve health

Treatment as prevention

Other: Social network and venue tracing

This is described in Arms 1 and 2

Other Name: This is described in Arms 1 and 2

Other: Community alerts

When we find recently or acutely infected participants, we will issue community alerts as described in Arm descriptions

Other: Community education

Throughout the study we will educate affected communities about recent and acute HIV infection and about the importance of avoiding stigma

Behavioral: HIV counseling

As part of HIV testing, we will provide participants with standard counseling

Active Comparator: HIV negative comparison arm

This comparison arm will consist of 150 uninfected people in each city whom we screen in the course of testing. The key comparisons here are on two of the central variables: adverse/supportive events and behavior change. This comparison arm will help mitigate social desirability effects that can lead to inaccurate reporting and/or Hawthorne effects and related processes that can lead to behavior changes simply based on the interview. Participants in this arm will be matched on age (within five years), risk group, and gender with an Arm 1 member.

Other: Assays

May vary across sites

Other Names:

Sedia Limited Avidity Assay

HIV antibody tests

HIV RNA testing

Other: Community alerts

When we find recently or acutely infected participants, we will issue community alerts as described in Arm descriptions

Other: Community education

Throughout the study we will educate affected communities about recent and acute HIV infection and about the importance of avoiding stigma

Behavioral: HIV counseling

As part of HIV testing, we will provide participants with standard counseling

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827228